Benign prostatic hypertrophy or benign adenomatous hyperplasia is a common condition found in both man and animals. The condition in man is found most frequently in those over 60 years of age. Various modes of treatment are available including prostatectomy. Although surgical removal of the prostate provides an effective method of treatment in some patients such treatment is undesirable being considered a risky, unwanted or excessive mode of therapy. Although the etiology of benign prostatic hypertrophy is unknown it has been suggested that changes in the androgen-estrogen level with advancing age may account for the condition. Hormonal treatment of the patient has been investigated as a possible means of therapy including the use of estrogens, androgens and combinations of androgens-estrogens. Although such treatment has been reported to often result in improvement of the condition certain undesirable side effects also occur. For example, it is known that prolonged administration of estrogens to males can result in the occurrence of gynecomastia and impotence. Also, estrogens are known to interfere with blood clotting mechanisms resulting in thrombosis and stroke. The method provided by the present invention avoids the undesirable side effects associated with estrogen therapy.
Some of the compounds employed in this invention, for example, 19-hydroxyandrost-4-ene-3,17-dione and the 19-oxo derivative thereof have been involved in numerous in vitro studies wherein the role of the metabolism of androgens has been investigated. Additionally, 19-hydroxyandrost-4-ene-3,17-dione is reported to have been administered to two healthy male subjects each 21 years of age (J. Clin. Endocrinol. Metab. 28 1401 (1968))). Also, 3-oxo-17.beta.-hydroxyandrost-4-ene-19-al has been reported in U.S. Pat. Nos. 3,235,573 issued Feb. 15, 1966, and 3,449,381 issued June 10, 1969, wherein the utilities disclosed are anabolic-androgenic activity, inhibition of pituitary gonadotrophins and adrenocorticotrophin, anti-estrogenic, blood, liver and adrenal cholesterol lowering properties, control of fertility and psychotic conditions, and appetite stimulants. To applicants' knowledge the use of the compounds employed in the present invention in the treatment of benign prostatic hypertrophy has not been taught or suggested heretofore.